Aortic catheter with porous aortic arch balloon

ABSTRACT

A method and device for perfusing an organ system is provided. The device may be further described as a catheter or cannula with an expandable flow control member positioned of the distal portion of the catheter shaft. The flow control member has a porous portion, and at least one impermeable portion, which prevent fluid from flowing out the ends of the flow control member. The flow control member is further characterized as having an interior chamber that is in fluid communication with a perfusion lumen that extends along the length of the catheter shaft and is in fluid communication with an external perfusion pump. The perfusion lumen is configured for providing flow to the interior of the flow control member, to create radial expansion thereof and to provide adequate flow to the arch vessels through said porous portion to sustain the metabolic demands of the brain.

FIELD OF THE INVENTION

[0001] The invention relates to a catheter or cannula system thatfacilitates cardiopulmonary surgeries and enables prolonged circulatorysupport of the heart. More specifically, the invention relates to anaortic catheter for segmenting and selectively perfusing the aortaduring cardiopulmonary bypass.

BACKGROUND OF THE INVENTION

[0002] Heart surgery has generally required major open chest surgicalprocedures that put the patient at risk. Relatively high mortality ratesand complications result from such invasive surgeries. Further, thesurgeries require extensive hospitalization and recuperation time.Surgical methods to correct heart problems are desirable which do notrequire open chest approaches. Some surgical techniques have beendescribed for particular applications employing an intra-aortic catheterintroduced into the vascular system of the patient.

[0003] Recent advances in the field of minimally invasive cardiacsurgery have included the development of aortic catheters and methodsfor inducing cardioplegic arrest without the necessity of opening thepatient's chest with a stemotomy or other major thoracotomy. Forexample, U.S. Pat. No. Re 35,352 to Peters describes a single-ballooncatheter for occluding a patient's ascending aorta and a method forinducing cardioplegic arrest. A perfusion lumen or a contralateralarterial cannula is provided for supplying oxygenated blood duringcardiopulmonary bypass. U.S. Pat. No. 5,584,803 to Stevens et al.describes a single balloon catheter for inducing cardioplegic arrest anda system for providing cardiopulmonary support during closed chestcardiac surgery. A coaxial arterial cannula is provided for supplyingoxygenated blood during cardiopulmonary bypass. The occlusion balloon ofthese catheters must be very carefully placed in the ascending aortabetween the coronary arteries and the arch vessels, therefore theposition of the catheter must be continuously monitored to avoidcomplications.

[0004] One difficulty encountered with prior art aortic catheters is thetendency of the single balloon catheters to migrate or drift in thedirection of the pressure gradient within the aorta. Specifically,during infusion of cardioplegia, the balloon catheter will tend to driftdownstream away from the heart and toward the aortic arch and, when thecardiopulmonary bypass pump is engaged during the procedure, the ballooncatheter will tend to drift upstream in the opposite direction towardthe heart into the aortic root. This migration can be problematic if theballoon drifts downstream far enough to occlude one or more of the archvessels, or upstream enough to occlude the coronary arteries, or to passthrough the aortic valve into the ventricle.

[0005] PCT patent application WO 9721462 by Fan et al. attempts toovercome this problem with a balloon catheter having high friction areason the outer surface of the balloon. A problem with this single balloonapproach is that a relatively large balloon is needed to create enoughfriction to avoid migration of the inflated balloon. The larger theballoon is, the more carefully it must be placed in the ascending aortato avoid occluding the coronary arteries or the arch vessels and theless margin of error there is should any balloon migration occur.

[0006] Furthermore, what is needed are medical instruments andcannula/catheters for compartmentalizing and selectively perfusing thecerebral circulation with antegrade flow. Such mechanisms are necessaryto minimize complications of a vast array that are related to propermanagement of blood flow in the body. Selective perfusion can be used toprioritize the flow of oxygenated blood or other protective fluids tothe various organ systems, therefore achieving optimal preservation ofall organ systems within the body.

[0007] Furthermore, what is needed is a peripheral access catheterconfiguration that is more resistant than prior apparatus to migrationdue to pressure gradients within the patient's aorta.

[0008] The following patents, and all other patents referred to herein,are hereby incorporated by reference in their entirety: U.S. Pat. Nos.5,308,320, 5,383,854, 5,820,93 and 5,906,588 by Safar et al.; U.S.patent application Ser. No. 08/909,293, filed Aug. 11, 1997, by Safar etal.; U.S. patent application Ser. No. 09/152,589, filed Sep. 11, 1998,by Safar et al.; U.S. Pat. No. 5,738,649, by John A. Macoviak; U.S.patent application Ser. No. 09/060,412 filed Apr. 14, 1998 by Macoviak;U.S. Pat. Nos. 5,833,671, 5,827,237 by John A. Macoviak and MichaelRoss; U.S. patent application Ser. No. 08/665,635, filed Jun. 17, 1996,by John A. Macoviak and Michael Ross; and U.S. patent application Ser.No. 09/205,753, filed Dec. 8, 1998, by Bresnahan et al.

SUMMARY OF THE INVENTION

[0009] Accordingly, the invention provides a catheter or cannula havinga flow control member positioned near the distal end of the catheter foroccluding a first body lumen at a point where a second body lumenbranches from the first lumen, and for perfusing the branch lumen. Theinvention will be described more specifically herein relating to anaortic catheter or cannula having an occlusion member positioned in theaortic arch, having a length sufficient to cover the ostia of the archvessels. The flow control member is intended to fulfill at least one andpreferably all four of the following functions: (1) occluding the aortaat the aortic arch, (2) selectively perfusing one or more of thecoronary arteries, the arch vessels, or the descending aorta with aselected fluid, (3) providing filtered perfusion to one or more of thecoronary arteries, the arch vessels, or the descending aorta, and (4)resisting migration of the distal flow control member and the cannula.

[0010] The primary flow control member may be formed in a variety ofconfigurations, but will include a primary flow control memberpositioned in the aortic lumen, having a length sufficient to cover theostia of the arch vessels. The flow control member may comprise one ormore inflatable balloons or one or more selectively deployable externalcatheter valves, or a combination of balloons and valves. In embodimentswhere the primary flow control member is a single inflatable balloon,the flow control member will have at least one permeable or meshportion. The balloons used, whether porous or nonporous, may be elasticso that they stretch in proportion to the inflation pressure, or may beflaccid or sack-like so that they inflate at low pressure and reachtheir design diameter quickly. The sack-like balloons may be relativelynon-compliant at their design diameter or they may be compliant,exhibiting elastic behavior after initial inflation, e.g. to closely fitthe aortic lumen size and curvature.

[0011] The catheter may further include one or more auxiliary flowcontrol members located upstream or downstream from the primary flowcontrol member to further segment the patient's circulatory system forselective perfusion to different organ systems or to assist in anchoringthe catheter in a desired position. Usable auxiliary flow controlmembers include, but are not limited to, expandable or inflatablemembers such as inflatable balloons and valves. Examples of variousvalves may include collapsible/expandable valves including retrogradevalves, antegrade valves, and various central flow and peripheral flowvalves. In addition, a combination of valves and inflatable members maybe used as appropriate for a given procedure. In some embodiments, thecatheter body can include one or more antegrade and retrograde valves,as well as one or more inflatable balloons. Inflatable balloons andcollapsible/deployable valves have been previously incorporated byreference herein and any desirable or practical inflatable balloon ordeployable valve may be used. Inflatable balloons typically include aninterior chamber that is in fluid communication with an inflation lumenextending within the catheter shaft from a location from within therespective flow control member to a location in the proximal portion,which is adapted to extend out of the patient.

[0012] Preferably, the flow control member, and any auxiliary flowcontrol members, or anchoring members, if present, are mounted on anelongated catheter shaft. In a preferred embodiment, the catheter shaftincludes at least one lumen for inflating or otherwise deploying theprimary flow control member and for perfusion of the arch vessels withoxygenated blood or other fluids, a lumen for corporeal perfusion, and aguidewire lumen. In alternate embodiments, lumens may be included fordeploying the auxiliary flow control members, and for measuring thepressure at desired locations within the aorta. The catheter may beconfigured for retrograde deployment via a peripheral artery, such asthe femoral artery, or it may be configured for antegrade deployment viaan aortotomy incision or direct puncture in the ascending aorta.

[0013] In some embodiments of the invention, filtration may be animportant feature. To capture embolic material without unduly disruptingblood flow, the porous section or sections must have an appropriatecombination of characteristics including effective filter surface areaand pore size; the correct combination depending on a number of factorsincluding fluid pressure. For filters comprised of a mesh, the threaddiameter is another important characteristic to consider. Typically, theflow rates required in the arch vessels total between 0.5 and 1.5 L/mindepending on a variety of factors including the size of the patient andthe temperature of the perfusate. Pore size is preferably 500 μm orless, more preferably 200 μm or less, and most preferably 50 μm or less,but larger than at least a red blood cell, although larger pore sizesmay be required in some embodiments.

[0014] Methods according to the present invention are described usingthe aortic catheter for occluding and compartmentalizing or partitioningthe patient's aortic lumen and for performing selective filtered aorticperfusion.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]FIG. 1 is a side view of a shaft portion of a first embodiment ofthe aortic catheter of the present invention having a single-balloonflow control member in the unexpanded state.

[0016]FIG. 2 is a magnified lateral cross section of the aortic cathetershaft of FIG. 1 taken along line 2—2.

[0017]FIG. 3 is a side view of the flow control member of the aorticcatheter of FIG. 1 showing a single-balloon flow control member in adeployed or expanded state.

[0018]FIG. 4 is a side view of the aortic catheter of FIG. 1 configuredfor retrograde introduction into a patient's femoral artery andillustrating the manifold connections to the proximal end of the aorticcatheter.

[0019]FIG. 5 is a side view of the aortic catheter of FIG. 1 deployed orexpanded in an aorta.

[0020]FIG. 6 is a side view of a shaft portion of a second embodiment ofan expanded or deployed single-balloon flow control member with a porouswindow.

[0021]FIG. 7 is a side view of the aortic catheter of FIG. 6 deployed orexpanded in the aorta of a patient, showing the porous window alignedwith the ostia of the arch vessels.

[0022]FIG. 8 is a side view of a third alternate embodiment of theprimary flow control member of the present invention wherein the porousmiddle portion of the primary flow control member has a deployeddiameter less than the deployed diameter of the proximal and distalends.

[0023]FIG. 9 is a side view of an alternate embodiment of the primaryflow control member of the invention with a porous window, where themiddle portion of the flow control member has a deployed diameter lessthan the deployed diameter of the proximal and distal ends of the flowcontrol member.

[0024]FIG. 10 is a side view of an embodiment where the flow controlmember of the invention comprises an inner balloon and an outer balloon.

[0025]FIG. 11 is a side view of an embodiment of the primary flowcontrol member wherein the primary flow control member is a compoundstructure comprised of three flow control elements.

[0026]FIG. 12 is a side view of another embodiment of the primary flowcontrol member wherein the primary flow control member is a compoundstructure comprised of two flow control elements deployed in a patientsaorta.

[0027]FIG. 13 is a side view of an embodiment of the primary flowcontrol member wherein the primary flow control member is a compoundstructure comprised of three flow control elements with a filter meshcoupled to and deployed between them.

[0028]FIG. 14 is a side view of another embodiment of the primary flowcontrol member wherein the primary flow control member is a compoundstructure comprised of two valve flow control elements and one porousinflatable balloon flow control member.

[0029]FIG. 15 is a side view of another embodiment of the primary flowcontrol member wherein the primary flow control member is a compoundstructure comprised of two end cap valve flow control elements and oneporous inflatable balloon flow control element partially received withineach valve element.

[0030]FIG. 16 is a side view of an embodiment of the primary flowcontrol member similar to that shown in FIG. 15, except the valveelements are conical.

[0031]FIG. 17 is a side view of the embodiment of the primary flowcontrol member similar to that shown in FIG. 15 deployed within apatient's aortic arch, and showing the distal valve element partiallycollapsed.

[0032]FIG. 18 is a side view of an embodiment of the primary flowcontrol member of the invention configured for antegrade deployment.

[0033]FIG. 19 is a side view of an embodiment the catheter of theinvention further comprising an auxiliary flow control member positionedin the patient's descending aorta.

DETAILED DESCRIPTION OF THE INVENTION

[0034] Turning now descriptively to the drawings, in which similarreference characters denote similar elements throughout the separateembodiments, the catheter described herein with all of its preferredfeatures represents a versatile device having multiple uses. Theinvention provides a catheter having a primary flow control memberpositioned near the distal end of the catheter for occluding a firstbody lumen at a point where a second body lumen branches from the firstbody lumen and for perfusing the branch lumen. However, the inventionwill be described more specifically herein relating to an aorticcatheter having a primary flow control member configured to bepositioned in the aortic arch and having a length sufficient to coverthe ostia of the arch vessels. The primary flow control member may haveat least one permeable or mesh portion in fluid communication with theostia of the arch vessels, and may be an inflatable balloon, or includeone or more inflatable balloons, or one or more selectively deployableexternal catheter valves as subunits thereof, or a combination ofballoons and valves as subunits thereof. The catheter is characterizedby a flexible catheter shaft placed by surgical cutdown orneedle/introducer guidewire technique into the vessels of the lower orupper extremity or neck. Larger internal vessels may also be used.Alternatively, the catheter may be introduced centrally through directpenetration of the ascending aorta.

[0035] In some embodiments, filtration may be an important feature ofthe invention. To filter blood and effectively capture embolic materialwithout unduly disrupting blood flow, the porous section or sectionsmust include an appropriate combination of characteristics includingeffective filter surface area and pore size, which combination will varydepending on a number of factors including the fluid pressure inside thecatheter. For filters comprised of a mesh, the thread diameter isanother important characteristic to consider. Typically, the flow ratesrequired in the arch vessels total between 0.5 and 1.5 L/min dependingon a variety of factors including the size of the patient and thetemperature of the perfusate. Pore size is preferably 500 μm or less,more preferably 200 μm or less, and most preferably 50 μm or less, butlarger than at least a red blood cell. However, small filter surfaceareas disclosed in some embodiments may require larger pore sizes thanthose given above in order to achieve the necessary rate of flow at anacceptable pressure.

[0036] Once appropriate physical characteristics are determined,suitable meshes can be found among standard meshes known in the art. Forexample, polyester meshes may be used, such as meshes made by SaatiCorporations and Tetko, Inc. These are available in sheet form and canbe easily cut and formed into a desired shape. Other meshes known in theart, which have the desired characteristics are also suitable.

[0037] Anticoagulants or antithrombogenic compounds may be applied tothe mesh to reduce the chances of blood clotting on the mesh. Theanticoagulants or antithrombogenic compounds may be painted, dipped,sprayed or chemically bonded onto the mesh and/or onto other parts ofthe catheter or the catheter lumens. Other methods known in the art forapplying anticoagulants or antithrombogenic compounds may also be used.Anticoagulants, such as heparin and heparinoids, may be used.Anticoagulants other than heparinoids may also be used, for examplemonoclonal antibodies such as ReoPro.

[0038] Perfusion of blood to the arch vessels will preferably beperformed with a pressure drop through the catheter and across thefilter of less than approximately 300 mm Hg, more preferably less thanapproximately 100 mm Hg, in order to reduce hemolysis while providing ablood flow preferably between 0.5 to 1.5 liters per minute. Preferredperfusion pressures may be different for perfusates that do not containblood and therefore are not subject to hemolysis.

[0039]FIG. 1 illustrates the shaft portion of a first embodiment of theinvention having a primary flow control member 110. FIG. 2 is amagnified lateral cross section of the aortic catheter taken along line2—2 in FIG. 1. The aortic catheter 100 has an elongated catheter shaft102 having a proximal portion 104 that preferably extends out of thepatient's body, and a distal end 106 adapted to extend into thepatient's aorta. The elongated catheter shaft 102 should have an overalllength sufficient to reach from the arterial access point where it isinserted into the patient to its deployed position within the aorta. Forfemoral artery deployment in adult human patients, the elongatedcatheter shaft 102 preferably has an overall length from approximately60 cm to 120 cm, and more preferably 70 cm to 90 cm.

[0040] Referring to FIG. 2, which is a cross section of the cathetershaft 102 taken along line 2—2 of FIG. 1, the elongated catheter shaft102 preferably has at least four lumens, an inflation/perfusion lumen108 that provides blood to the primary flow control member 110 and tothe arch vessels through the flow control member perfusion ports 112, apressure lumen 114 opens to a pressure port 177, a guidewire lumen 116,and a corporeal perfusion lumen 118 that is used to perfuse thedescending aorta through the corporeal perfusion ports 126. Theconfiguration of the lumens shown is for illustrative purposes only, andother configurations may be used. For example, in alternate embodimentsthe catheter shaft 102 may not include a corporeal perfusion lumen 118or pressure lumen 114 that will help simplify the manufacture of theaortic catheter 100. In configurations where corporeal perfusion is notintegrally built into the aortic catheter, corporeal perfusion may beprovided by a coaxial, collateral or contralateral arterial cannula.Alternatively, additional lumens may be included such as perfusionlumens, monitoring lumens or validation of catheter placement lumens.

[0041] In a preferred embodiment, the elongated catheter shaft 102 hasan outer diameter that is preferably approximately 9 to 26 French (3.0to 8.7 mm), and more preferably 12 to 18 French (4.0 to 6.0 mm) for usein adult human patients. Catheters for pediatric use, or use innon-human subjects, may require different dimensions and would be scaledaccordingly. The elongated catheter shaft 102 is preferably formed of aflexible thermoplastic material, a thermoplastic elastomer, or athermoset elastomer. Suitable materials for use in the elongatedcatheter include, but are not limited to, polyvinylchloride,polyurethane, polyethylene, polyamides, polyesters, silicone, latex, andalloys or copolymers thereof, as well as braided, coiled or counterwoundwire or filament reinforced composites.

[0042] The primary flow control member 110, of FIG. 1, is mountedproximal the distal end 106 of the elongated catheter shaft 102 oralternatively may extend beyond the distal end 106. The flow controlmember 110 is intended to fulfill at least one and preferably all fourof the following functions: (1) occluding the aorta at the aortic arch,(2) selectively perfusing one or more of the coronary arteries, the archvessels, or the descending aorta with a selected fluid, (3) providingfiltered perfusion to one or more of the coronary arteries, the archvessels, or the descending aorta, and (4) resisting migration of theprimary flow control member 110 or cannula 100.

[0043]FIG. 3 illustrates the flow control member 110 of FIG. 1 in theexpanded or deployed position. The expandable flow control member may bemounted to the exterior of the catheter shaft by heat bonding, heatwelding, with an adhesive or by mechanical or frictional means. The flowcontrol member 110 comprises a balloon having a distal end 120, a middleportion 122, and a proximal end 124. The distal end 120 and the proximalend 124 are preferably formed of a nonporous material creating at leastone occlusive end, while the middle portion is preferably formed of amesh or porous material. The inflatable flow control member 110 has adeflated state 110′ as illustrated with reference to FIG. 1, in whichthe diameter of the flow control member is, preferably, notsubstantially larger than the diameter of the catheter shaft 102 and aninflated state 108 in which the flow control member 110 expands to adiameter sufficient to at least partially occlude blood flow in theaortic arch of a patient. For use in adult humans, the flow controlmember 110 preferably has an inflated outer diameter of approximately 1to 7 cm more preferable 2 to 5 cm. When the primary flow control member110 comprises an inflatable balloon, whether porous or nonporous, theinflatable balloon may be elastic so that it stretches in proportion tothe inflation pressure, or may be flaccid or sack-like so that itinflates at low pressure and reaches its design diameter quickly. Thesack-like balloon may be relatively non-compliant at its design diameteror it may be compliant, exhibiting elastic behavior after initialinflation, to closely fit the aortic lumen size and curvature. Thematerial or materials used in the inflatable primary flow control member110 is preferably characterized by properties that allow an internalpressure within the distal flow control member 110 to be maintained at asufficient level to occlude the aorta, while also allowing a controlledvolume of fluid to escape from the flow control member for perfusing thearch vessels. Suitable materials which may be used for flow controlmember 110 include polyurethanes, polyethylene terephthalate (PET),polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), latex andpolyolefin. Furthermore, the surface of the flow control member may haveporous regions that allow a fluid to be perfused at a known rate when aspecific pressure is attained while not allowing other porous regions toopen until a greater internal pressure in the balloon is attained. Forperfusion of the arch vessels, it is preferable that the flow rateprovided to the arch vessels be controllable within a range from 0.1 to2.0 liters per minute, and more preferably within a range from 0.5 to1.5 liters per minute, depending on a variety of factors. Therefore, theflow control member 110 has material properties that allow for theaforementioned perfusion range while still maintaining occlusionproperties when deployed in the aorta.

[0044] The porous and nonporous sections of the primary flow controlmember 110 may be formed from the same or separate materials. Suitablematerials for the nonporous portions of the inflatable flow controlmember 110 include, but are not limited to, elastomers, thermoplasticelastomers, polyvinylchloride, polyurethane, polyethylene, polyamides,polyesters, silicone, latex, and alloys or copolymers, and reinforcedcomposites thereof. In addition, the outer surface of the flow controlmember 110 may include a force or friction increasing means such as afriction increasing coating or texture to increase friction between thedistal flow control member 110 and the aortic wall when deployed.Suitable materials for the mesh or porous middle portion 122 include,but are not limited to, a perforated polymer film, porous or microporousmembranes, TYVEK (spun-bonded polyethylene), GORTEX (expanded PTFE),woven or knit mesh or fabric, or the like.

[0045] Referring now to FIG. 4, to facilitate placement of the catheter100 within the aorta, and to improve the stability of the catheter 100in the proper position in the patient's aorta, a distal region 130 ofthe aortic catheter 100 may be preshaped to conform to the internalcurvature of the patient's aortic arch. The distal region 130 representsa J-shaped curve of approximately 180 degrees of arc with a radius ofcurvature of approximately 2 to 4 centimeters, for use in a typicaladult human patient and may be reinforced with polymer filaments ormetal or both. The distal end 106 of the aortic catheter 100 may also beskewed slightly out of the plane reflecting the forward angulation ofthe typical patient's ascending aorta.

[0046] The proximal end/portion 104 of the aortic catheter 100 hasfittings for each of the catheter lumens 108, 114, 116, and 118. Thecorporeal perfusion lumen 118 is coupled to a Y-fitting 134 having abarb connector 136 for connection to a perfusion pump or the like, and aluer connector 138 for injecting medications or other fluids. Inalternate embodiments, the catheter shaft 102 may further include apressure lumen coupled to a luer connector for monitoring the corporealperfusion pressure, withdrawing fluid samples, or for injectingmedications or other fluids. The flow control member deployment andperfusion lumen 108 is coupled to a Y-fitting 140 having a barbconnector 142 for connection to the same perfusion pump 900 a perfusionpump or the like, and a luer connector 144 for injecting medications orother fluids. The arch pressure lumen 114 is coupled to a luer connector146 for monitoring the arch perfusion pressure, withdrawing fluidsamples, or for injecting medications or other fluids. The guidewirelumen 116 is coupled to a Touhy-Borst fitting 148, or other hemostasisvalve. In alternate embodiments having an auxiliary flow control memberand where separate lumens are desired for deploying the auxiliary flowcontrol member, additional fittings suitable for connecting to a syringeor other inflation or deployment device would be provided.

[0047] Illustrated in FIG. 5 is the flow control member 110 deployed inthe aorta illustrating the functional features and material attributesof the control member 110 in use. The flow control member 110 ispositioned within the aortic arch with the porous middle portion 122covering the ostia of the arch vessels. A selected fluid, such asoxygenated nonnothermic blood, oxygenated hypothermic blood, bloodsubstitutes such as PERFLUBRON or other perfluorocarbon compounds,radiopaque dyes for angiography, or the like, is introduced through theflow control member inflation and perfusion lumen 108 into theinflatable flow control member 110. Some selected fluid may seep outthrough the porous middle portion 122 during inflation, but at a rateless than the rate at which the selected fluid enters the flow controlmember 110. In an alternate embodiment, it may be preferable toinitially inflate the flow control member 110 with a more viscoussolution, for example a radiopaque contrast agent mixed with saline,that will flow through the porous middle portion 122 at a rate slowerthan the selected perfusion fluid will leak.

[0048] When the correct pressure is attained, the flow control member110 occludes blood flow through the aortic lumen. The selected fluidused to inflate the flow control member 110 may escape through theporous portion 122 at a known rate into the arch vessels. The flow ratemay be adjustable by adjusting the pressure within the flow controlmember 110. Contact with the aortic wall and the middle porous portion122 of the flow control member 110 will reduce or prevent seepage of theselected fluid through sections of the porous middle portion 122 of theflow control member 110 not aligned with the arch vessels. The middleporous portion 122 of the flow control member 110 contacting the aorticwall may also provided resistance to the migration of the flow controlmember 110 or cannula 100.

[0049] Preferably, the aortic catheter 100 includes one or more locationmarkers 128, such as radiopaque markers and/or sonoreflective markers,to enhance imaging of the aortic catheter 100 during deployment usingstandard fluoroscopy, ultrasound, MRI, MRA, transesophagealechocardiography, or other techniques. A radiopaque location marker 128may be formed as a ring or disk of dense radiopaque metal such as gold,platinum, tantalum, tungsten, or compounds or alloys thereof, or a ringof a polymer or adhesive material heavily loaded with a radiopaquefiller material.

[0050] In use, the catheter 100 is advanced up the descending aorta andacross the aortic arch, under fluoroscopic or ultrasound guidance withthe aid of a guidewire within the guidewire lumen 116. The aorticcatheter 100 is advanced until the primary flow control member 110 ispositioned in the aortic arch. This may be determined by reference tothe radiopaque marker or markers 128. Using a multihead cardiopulmonarybypass pump or the like, perfusion of oxygenated blood is startedthrough the perfusion ports 112. The flow control member 110 is theninflated to occlude the aortic arch using a selected perfusion fluidsuch as oxygenated blood. When the correct pressure is achieved, theperfusion fluid flows from the flow control member 110 and enters thearch vessels. The rate of flow of the perfusion fluid may be controlledby adjusting the pressure within the flow control member 110. At thecompletion of the surgical procedure, the flow control member 110 isallowed to deflate, allowing oxygenated blood to flow from the heart tothe arch vessels, the descending aorta, and to the coronary arteries.The heart should then spontaneously resume normal sinus rhythm, however,if necessary, cardioversion or defibrillation shocks may be applied torestart the heart. The patient is then weaned off the bypass and theaortic catheter, and other cannulas, are withdrawn. The alternateembodiment configured for antegrade deployment would be used similarly,except that access to the patient's circulatory system would be madethrough a central access by an aortotomy or incision directly into theascending aorta.

[0051] Modification of the operational characteristics or procedures setforth above for use in vessels other than the aorta for perfusion ofblood to branch vessels are readily ascertainable by those skilled inthe art in view of the present disclosure.

[0052] In an alternate embodiment seen in FIGS. 6 and 7, the flowcontrol member 150 comprises a nonporous balloon with a porous window152. In this variation, the catheter 100 may be made of the samematerials as those described in relation to the catheter 100 of FIGS. 1through 5. Common numbers refer to common assembly components, thereforethe description of these parts as explained in connection with FIGS. 1through 4 is incorporated by reference into this illustrative embodimentand all others to follow. The relative position, size and shape of theporous window 152 is provided only as an example and any size shape orconfiguration may be implemented. In this example, the porous window 152is positioned approximately symmetrically with respect to theballoon-shaped flow control member 150. FIG. 7 shows the aortic catheterof FIG. 6 deployed within a patient's aorta illustrating the relativeposition of the porous window 152 relative to the ostia of the archvessels. In this example, the porous window 152 is positionedasymmetrically with respect to the balloon-shaped flow control member150 to accommodate a variation in the geometry of a patient's aorticarch.

[0053] In an alternate embodiment shown in FIG. 8, the flow controlmember 160 includes a porous middle portion 162 with an inflated ordeployed diameter less than the diameter of the aortic lumen when theproximal 124 and distal 120 ends are expanded and occluding the aorta.In the embodiments wherein the middle porous section contacts the aorticlumen the effective perfusion area may be limited to the area at theopenings of the ostia since the rest of the porous portion will beeffectively occluded by the aortic wall. The advantage of theconfiguration associated with FIG. 8 is that the middle porous section162 avoids substantial contact with the aortic wall allowing a greatereffective filter and perfusion surface area to the arch vessels sinceperfusion is free to pass through all the mesh material and into thearch vessels. This enables a finer mesh to be used since the effectivefilter and perfusion surface area is not limited to the openings of thearch vessels.

[0054] The occlusion member 160 of FIG. 8 may be made of differentmaterials which will enable the proximal and distal ends to be moreeasily inflatable or expandable than the middle porous portion 162 whichhas the resultant effect of differing outer diameter proportions. Forexample, the proximal 124 and distal 120 ends may be made of a flexibleelastomer such as silicone or latex and the middle portion may be madeof a less flexible polyurethane or nylon. Alternatively, another way toachieve the larger ends and a narrower middle portion is to usemechanical supports, external clamps, external heat shrink or the likeon the middle portion to essentially restrict the middle portionrelative to the ends. In addition, a single material can be used and thedesired shape can be achieved by varying the wall thickness of theocclusion member 160. For example, dipping, molding or extruding theocclusion member are all methods, which may be utilized for creating anocclusion member having a varying wall thickness. Furthermore, the endsof the occlusion member 160 may be fatigued through the manufacturingprocess to create a thinner or more flexible material.

[0055] The embodiment seen in FIG. 9 discloses a flow control member 170comprising a nonporous balloon with a porous window 172. The relativeposition, size and shape of the porous window 172 is provided only as anexample, and in other embodiments the porous window 172 may be anydesirable position, size or shape. The catheter of FIG. 9 is otherwisesimilar to the catheter of FIG. 8 as previously described, and the samebenefit of increased filter surface area may be obtained. In thisembodiment, the smaller diameter of the middle portion also reduces thecriticality of positioning the window 172 over the ostia of the archvessels.

[0056] In another embodiment, seen in FIG. 10, a flow control member 180comprises a first outer flow control element or outer balloon 187 and asecond inner flow control element or inner balloon 184 positioned withinthe first outer balloon 187. The first outer balloon 182 comprises aporous material or includes one or more porous sections 182. The secondinner balloon 184 is preferably nonporous. When the second inner balloon184 is fully inflated, the outer surface of the second inner balloon 184contacts the inner surface of the first outer balloon 187 preventingescape of perfused fluid through the porous sections of the first outerballoon 187. When the first inner balloon 187 is fully or partiallydeflated, perfusion is allowed to resume through outer balloon 187. Inthis embodiment, separate lumens connecting to the outer balloon port186 and the inner balloon port 181 are required for inflating anddeflating the first outer balloon 182 and the second inner balloon 184independently of each other.

[0057] In embodiments seen in FIGS. 11 through 17, the catheter 100 isshown and will be described having a flow control member comprising aplurality of flow control elements. For example, FIG. 11 discloses aflow control member 190 comprising a set of three adjacent flow controlelements. In this embodiment, the flow control elements include a firstballoon 192, a second balloon 194, and a third balloon 196. In alternateembodiments, any desirable or practical valves, may be substituted forballoons 192 and 196.

[0058] The first balloon 192, located nearest the distal end 106 of theaortic catheter 100, is preferably comprised of a nonporous material,and is intended to occlude the ascending aorta between the coronaryarteries and the arch vessels, and to prevent fluid perfused through thesecond porous balloon 194 from entering the ascending aorta in aretrograde direction. The second porous balloon 194 is positionedadjacent the proximal side of the first balloon 192. The second balloon194 is preferably formed of a porous material, includes porous sections,or includes other means for allowing a controlled flow rate of perfusedfluid to pass through. The third balloon 196 is located adjacent thesecond balloon 194 and is preferably comprised of a nonporous material.In variations where the aortic catheter 100 is to be introduced directlyinto the ascending aorta the balloon position is reversed relative tothe aorta such that the first occlusion balloon 192 resides in thedescending aorta and the third occlusion balloon 196 resides in theascending aorta. The purpose of the third balloon 196 is primarily foroccluding the aorta to prevent fluid perfused through the porous secondballoon 194 from entering the descending aorta. The porous secondballoon 194 may be configured with a deployed diameter equal to orgreater than the aortic lumen in order to contact the aortic wall afterinflation, or it may be configured with a deployed diameter smaller thanthe aortic lumen so that, after inflation, it is not in substantialcontact with the aortic lumen. The advantage of configuring the secondporous balloon 194 to contact the aortic wall is that the force orfriction generated by contact with the aortic wall may resist migrationof the flow control member 190. The advantage of configuring the poroussecond balloon to avoid substantial contact with the aortic wall is thata greater effective filter surface area is achieved because perfusionmay not be limited to passing through the mesh material over the archvessels, consequently, a finer mesh may be used while still achieving adesired flow rate at a desired pressure.

[0059] Another embodiment of the distal flow control member is seen inFIG. 12, which discloses a flow control member 200 comprising two flowcontrol elements 202 and 204 spaced apart so that, in use, one flowcontrol element is positioned on each side of the arch vessels. In theembodiment shown, the flow control elements 202 and 204 compriseinflatable balloons. The first flow control element 202, located nearestthe distal end of the aortic catheter 200, preferably comprises anonporous section 206 on the distal side of the flow control element202, and a porous section 208 located on the proximal side of the flowcontrol element 202. The second flow control element 204 preferablycomprises a nonporous section 210 located on the proximal side of theflow control element 204, and a porous section 212 located on the distalside of the flow control element 204. The deployment/perfusion ports 206are located in the first and second flow control elements 202 and 204.The same or separate inflation/perfusion lumens may be used for flowcontrol elements 202 and 204. In an alternate embodiment, only one ofthe balloons 202 or 204 may include a porous section. Alternatively, thefirst flow control element 202 and second flow control element 204 maybe reversed in orientation such that the non-permeable portions arereversed with respect to the permeable portions. In this position,cardioplegia may be delivered to the aortic root through permeableportion 208 while blood is delivered to the corporeal body throughpermeable portion 212 and the arch receives blood through arch perfusionports 112 at a flow sufficient to maintain the viability of the brain.

[0060]FIG. 13 discloses a flow control member 220 comprising two flowcontrol elements 222 and 224 spaced apart, as in the previousembodiment, so that, in use, one flow control element is positioned oneach side of the arch vessels. However in this embodiment, a mesh orporous filter 226 is coupled between the balloons. In this embodiment,the first and second flow control elements 222 and 224 are nonporousballoons. The balloons may be deployed by using a singledeployment/perfusion lumen, or in alternate embodiments, a separatelumen may be used to deploy the flow control elements 222 and 224independently.

[0061] In alternate embodiments, valves of various varieties, such asthose described in U.S. Pat. No. 5,833,671, 5,827,237 by John A.Macoviak and Michael Ross; and U.S. patent application Ser. No.08/665,635, filed Jun. 17. 1996, by John A. Macoviak and Michael Rosswhich have previously been incorporated by reference may be used insteadof one or more of the inflatable balloons of the flow control elementspreviously described. For example, FIG. 14 discloses a primary flowcontrol member 240 similar to that disclosed in FIG. 12, comprising afirst flow control element 242, a second flow control element orinflatable balloon 244, and a third flow control element 246. However,in this embodiment, flow control elements 242 and 246 are valves. Anydesirable or practical valves, such as those described in U.S. Pat. Nos.5,833,671, 5,827,237 by John A. Macoviak and Michael Ross; and U.S.patent application Ser. No. 08/665,635, filed Jun. 17, 1996, by John A.Macoviak and Michael Ross, may be substituted for balloons 192 and 196which have been described in the previous embodiments. Flow controlelement 244 is an inflatable balloon comprising a porous material orhaving porous sections or the like.

[0062] The first flow control element 242 is located nearest the distalend 106 of the aortic catheter 100, and is intended to occlude theascending aorta between the coronary arteries and the arch vessels whenintroduced in the retrograde direction by way of femoral access and issized and configured to prevent fluid perfused through the balloon 244from entering the ascending aorta in a retrograde direction. The thirdflow control element 246 is positioned adjacent the distal side of theballoon 244. The purpose of the third flow control element 246 isprimarily for occluding the aorta to prevent fluid perfused through thesecond porous balloon from entering the descending aorta and to isolatecardioplegia. The balloon 244 may be configured with a deployed diameterequal to or greater than the aortic lumen in order to contact the aorticwall after inflation, or it may be configured with a deployedcircumference smaller than the aortic lumen so that, in use, it is notin substantial contact with the aortic lumen. The advantage ofconfiguring the balloon 244 to contact the aortic wall is that the forceor friction generated by contact with the aortic wall may resistmigration of the flow control member 240 or cannula 100. The advantagein configuring the balloon 244 to avoid substantial contact with theaortic wall is that a greater effective filter surface area is achievedbecause perfusion is not limited to passing through the mesh material ofthe balloon 244 over the arch vessels. Consequently, a finer mesh may beused. Preferably the catheter shaft 102 includes one or more lumens fordeployment of the flow control elements 242 and 246 separate from theinflation/perfusion lumen for balloon 244.

[0063] In the embodiment shown in FIG. 15, the flow control member 250is shown with valves 252 and 256 being end cap valves that are deployedby inflation or deployment of the second flow control element 254.Consequently, the end cap valves 252 and 256 do not require separatedeployment lumens, as deployment of the inflatable middle flow controlelement 254 will deploy them. The end cap valves may be any desiredshape or configuration. For example, FIG. 16 shows a flow control member260 similar to that disclosed in FIG. 15, but with conical end capvalves 262 and 266. The end cap valves may be made of any suitablematerials such polyarethanes, polyethylene terephthalate (PET),polyvinyl chloride (PVC), polyolefin, latex and ethylene vinyl acetate(EVA).

[0064]FIG. 17 shows the embodiment of the catheter of FIG. 15 deployedin an aorta with the first flow control element 252 shown in asemi-collapsed condition. It may be an advantage to wean a patient offcardiopulmonary bypass slowly, after the completion of a procedure, byproviding a means for transitioning between complete occlusion of theaorta and perfusion by cardiopulmonary bypass and normal heart function.Reducing the pressure in the second flow control member reduces thesupport of the flow control members 252 and 256. Fluid pressuregenerated by contraction of the ventricle temporarily partiallycollapses the flow control element 252. Thus, by adjusting the pressurein the second flow control element 254 downward, a controlled flow ofblood from the heart is allowed to enter the arch vessels and/or thedescending aorta.

[0065] The previous embodiments have been described using a catheterconfigured for a retrograde approach to the aorta from a peripheralvessel such as the femoral artery. Each of the described embodiments ofthe invention could easily be modified for alternate deployment means.For example, FIG. 18 shows a catheter 100 configured for centralantegrade deployment in the aortic arch through an aortotomy or directpuncture in the ascending aorta. The catheter 100 and flow controlmember 270 is configured similarly to that disclosed in FIG. 3,comprising an inflatable balloon with nonporous sections 272 and 276,and a porous middle portion 274. In this embodiment, the guidewire lumen116 may be used for corporeal perfusion after the guidewire is removedor alternatively a separate catheter may be inserted either into thefemoral artery or the subclavian to perfuse the corporeal circulation,or alternatively corporeal perfusion can be provided through a corporeallumen 118 and downstream corporeal port 126 distal to the flow controlmember 270. Other embodiments of the invention may be configured forperipheral insertion through the subclavian, femoral or auxiliaryarteries, as can be seen in U.S. patent application Ser. No. 09/205,753.

[0066] Any embodiments of the catheter of the invention described abovemay further include auxiliary flow control members. The auxiliary flowcontrol members may be used to further compartmentalize the patient'scirculatory system, or may be used for other functions such as assistingin securely anchoring the catheter in a chosen position. Accordingly,the auxiliary flow control members may be inflatable balloons,deployable valves, or combinations thereof. An example of an auxiliaryflow control member is seen in FIG. 19. The catheter of FIG. 19 isconfigured similarly to the catheter disclosed in FIG. 4, except thatthe catheter of FIG. 19 comprises an additional or auxiliary flowcontrol member 292 coupled to the catheter shaft 102 proximate, butspaced apart from, the primary flow control member 290. The auxiliaryflow control member 292 is mounted to the distal portion of the cathetershaft 102 proximal to, but spaced apart from, the primary flow controlmember 290. The distance between the primary flow control member 290 andthe auxiliary flow control member 292 is between approximately 0.5 cmand 10 cm, and is chosen so that when the aortic catheter 100 isdeployed with the primary flow control member 290 over the ostia of thearch vessels, the auxiliary flow control member 292 will be positionedin the descending aorta. Use of an auxiliary flow control member 292 toanchor the catheter 100 may allow the use of a lower inflation pressurein the porous balloon as it is no longer depended on for preventingmigration of the catheter 100. This may avoid possible damage to theaorta, which may result from the use of higher pressures to preventmigration.

[0067] The auxiliary flow control member 292 is shown in this embodimentin the form of an expandable inflatable balloon bonded to the cathetershaft 202 by heat welding or with an adhesive. The auxiliary flowcontrol member 292 preferably has a length that is longer than thelength of the primary flow control member 290, or alternatively may beshorter so long as the function of anchoring the catheter 100 isaccomplished. Suitable materials for the inflatable anchor member 292include, but are not limited to, elastomers, thermoplastic elastomers,polyvinylchloride, polyurethane, polyethylene, polyamides, polyesters,silicone, latex, and alloys or copolymers and reinforced compositesthereof In addition, the outer surface of the anchor member 292 mayinclude a friction increasing means such as a friction increasingcoating or texture to increase friction between the anchor member 292and the aortic wall when deployed. In the embodiment shown, thecorporeal perfusion ports 126 are located on the catheter shaft 102proximate the anchoring member.

[0068]FIG. 19 illustrates the aortic catheter 100 of the presentinvention deployed in the aorta illustrating the functional features andmaterial attributes of the flow control member 290 in use. The flowcontrol member 290 is positioned within the aortic arch with the porousmiddle portion 274 covering the ostia of the arch vessels. A selectedfluid, such as oxygenated normothermic blood, oxygenated hypothermicblood, blood substitutes such as PERFLUBRON or other perfluorocarboncompounds, radiopaque dyes for angiography, or the like, is introducedthrough the flow control member inflation and perfusion lumen 108 intothe inflatable flow control member 290. Some selected fluid may seep outthrough the porous middle portion 274 during inflation, but at a rateless than the rate at which the selected fluid enters the flow controlmember 290. In an alternate embodiment, it may be preferable toinitially inflate the flow control member 290 with a more viscoussolution, for example a radiopaque contrast agent mixed with saline,that will flow through the porous middle portion 274 at a rate slowerthan the selected perfusion fluid will leak.

[0069] When the correct pressure is attained, the flow control member290 occludes blood flow through the aortic lumen. The selected fluidused to inflate the flow control member 290 may escape through theporous portion 274 at a known rate into the arch vessels. The flow ratemay be adjustable by adjusting the pressure within the flow controlmember 290. Contact with the aortic wall and the middle porous portion274 of the flow control member 290 will reduce or prevent seepage of theselected fluid through sections of the porous middle portion 274 of theflow control member 290 not aligned with the arch vessels. The middleporous portion 274 of the flow control member 290 contacting the aorticwall may also provided resistance to the migration of the flow controlmember 290 or cannula 100.

[0070] Preferably, the aortic catheter 100 includes one or more locationmarkers 128, such as radiopaque markers and/or sonoreflective markers,to enhance imaging of the aortic catheter 100 during deployment usingstandard fluoroscopy, ultrasound, MRI, MRA, transesophagealechocardiography, or other techniques. A radiopaque location marker 128may be formed as a ring or disk of dense radiopaque metal such as gold,platinum, tantalum, tungsten, or compounds or alloys thereof, or a ringof a polymer or adhesive material heavily loaded with a radiopaquefiller material.

[0071] In use, the catheter 100 is advanced up the descending aorta andacross the aortic arch, under fluoroscopic or ultrasound guidance withthe aid of a guidewire within the guidewire lumen 116. The aorticcatheter 100 is advanced until the primary flow control member 290 ispositioned in the aortic arch. This may be determined by reference tothe radiopaque marker or markers 128. Using a multihead cardiopulmonarybypass pump or the like, perfusion of oxygenated blood is startedthrough perfusion lumen 108 and out the perfusion ports 112. The flowcontrol member 290 is then inflated to occlude the aortic arch using aselected perfusion fluid such as oxygenated blood. When the correctpressure is achieved, the perfusion fluid flows from the flow controlmember 290 and enters the arch vessels. The rate of flow of theperfusion fluid may be controlled by adjusting the pressure within theflow control member 290. At the completion of the surgical procedure,auxiliary member 292 is deflated and thereafter the flow control member290 is allowed to deflate, allowing oxygenated blood to flow from theheart to the arch vessels, the descending aorta, and to the coronaryarteries. The heart should then spontaneously resume normal sinusrhythm, however, if necessary, cardioversion or defibrillation shocksmay be applied to restart the heart. The patient is then weaned off thebypass and the aortic catheter, and other cannulas, are withdrawn. Thealternate embodiment configured for antegrade deployment would be usedsimilarly, except that access to the patient's circulatory system wouldbe made through a central access by an aortotomy or incision directlyinto the ascending aorta.

[0072] In use, the aortic catheter 100 of any of the embodimentsdescribed above is introduced into the patient's circulatory systemthrough a peripheral artery such as the femoral artery, by thepercutaneous Seldinger technique, through an introducer sheath, via anarterial cutdown or centrally by means of a median sternotomy ormini-thorocotmy.

[0073] Modification of the operational characteristics or procedures setforth above for use in vessels other than the aorta for perfusion ofblood to branch vessels are readily ascertainable by those skilled inthe art in view of the present disclosure.

What is claimed is:
 1. A catheter for perfusing a branch lumen connectedto a first body lumen in a patient comprising: an elongated cathetershaft configured for introduction into the first body lumen of thepatient, said catheter shaft having a proximal end and a distal end, aflow control member coupled to said elongated catheter shaft having anexpanded diameter sufficient to block blood flow through the first bodylumen when deployed, said flow control member comprising a distalimpermeable portion, a middle portion, and a proximal impermeableportion, said middle portion comprising a porous section, whereby afluid used to inflate said flow control member is capable of perfusingthrough said middle portion to perfuse the branch lumen.
 2. The catheterof claim 1, wherein said middle portion comprises one or more porouswindows.
 3. The catheter of claim 1, wherein said middle portion has adeployed diameter at least as large as the interior diameter of thefirst body lumen.
 4. The catheter of claim 3, wherein contact of anouter surface of said middle portion with an interior surface of saidfirst lumen creates sufficient friction force to resist migration ofsaid catheter.
 5. The catheter of claim 1, wherein said middle portionhas a deployed diameter smaller than said first body lumen.
 6. Thecatheter of claim 1, wherein a known rate of perfusion can beestablished by adjusting the pressure within the flow control member. 7.The catheter of claim 1, further comprising at least one auxiliary flowcontrol member coupled to said elongated catheter distal to said flowcontrol member.
 8. The catheter of claim 1, further comprising at leastone auxiliary flow control member coupled to said elongated catheterproximal to said flow control member.
 9. The catheter of claim 1,wherein said middle portion comprises a filter.
 10. The catheter ofclaim 1, wherein said middle portion is comprised of a filter material.11. The catheter of claim 2, wherein said at least one porous windowcomprises a filter.
 12. An aortic catheter comprising: an elongatedcatheter shaft configured for introduction into a patient's aorta andhaving a proximal end and a distal end; and a flow control assemblycoupled to said elongated catheter having at least one expanded diametersufficient to block blood flow through the aortic arch when deployed;and said flow control assembly comprising at least one porous inflatablemember, whereby a fluid used to inflate said at least one porousinflatable member is configured for perfusing at a known rate throughsaid at least one porous inflatable member to perfuse the arch vessels.13. The catheter of claim 12, wherein said at least one porousinflatable member comprises one or more porous windows.
 14. The catheterof claim 12, wherein said at least one porous inflatable member has adeployed diameter at least as large as the aortic lumen at the aorticarch.
 15. The catheter of claim 12, wherein contact of an outer surfaceof said at least one porous inflatable member with the inner surface ofsaid aortic lumen creates sufficient friction force to resist migrationof said catheter.
 16. The catheter of claim 12, wherein said at leastone porous inflatable member has a deployed diameter smaller than theaortic lumen at the aortic arch.
 17. The catheter of claim 12, wherein aknown rate of perfusion can be established by adjusting the pressurewithin said at least one porous inflatable member.
 18. The catheter ofclaim 12, further comprising at least one auxiliary flow control membercoupled to said elongated catheter distal to said flow control member.19. The catheter of claim 12, further comprising at least one auxiliaryflow control member coupled to said elongated catheter proximal to saidflow control member.
 20. The catheter of claim 12, wherein said at leastone porous inflatable member comprises a filter.
 21. The catheter ofclaim 13, wherein said at least one porous window comprises a filter.22. A catheter for perfusing a branch lumen connected to an aortic archlumen in a patient comprising: a catheter shaft having a distal endconfigured to be inserted into the first body lumen of the patient andnavigated into the aorta and a proximal portion extending outside thefirst body lumen of the patient when said distal end is in an operativeposition and wherein said proximal portion is in fluid communicationwith an external perfusion pump and is configured to provide blood flowto the cerebral circulation through at least one perfusion port in theexterior of said catheter shaft and at a flow rate sufficient tomaintain the viability of the brain; a flow control member positionedproximate the distal end of the catheter shaft configured for expandingfrom said catheter shaft to at least partially occlude the aorta whereinsaid flow control member has a porous portion and at least one occlusiveend, said porous portion having permeable portions of sufficient size toallow fluid to flow therethrough to the arch vessels and said at leastone occlusive end is sized and dimensioned such that when placed in theoperative position upstream of the brachiocephalic artery said occlusiveend capable of expanding radially to a diameter at least the size of theinside diameter of a patient's aorta; and a corporeal perfusion lumenhaving a distal end configured to reside inside the internal lumen ofthe patient's aorta when placed in an operative position and a proximalportion extending outside the body lumen of the patient configured forbeing coupled to said external perfusion pump and of sufficient size andinternal diameter to communicate fluid from said external perfusion pumpto a corporeal perfusion port proximate said external end to sustain themetabolic demands of the corporeal body.
 23. The aortic catheter ofclaim 22, wherein said porous portion comprises one or more porouswindows.
 24. The catheter of claim 22, wherein said porous portion has adeployed diameter less than the deployed diameter of said occlusive end.25. The catheter of claim 22, wherein a known rate of perfusion can beestablished by adjusting the pressure within the flow control member.26. The catheter of claim 22, further comprising at least one auxiliaryflow control member coupled to said elongated catheter distal to saidflow control member.
 27. The catheter of claim 22, further comprising atleast one auxiliary flow control member coupled to said elongatedcatheter proximal to said flow control member.
 28. The catheter of claim22, wherein said porous portion comprises a filter.
 29. The catheter ofclaim 22, wherein said porous portion is comprised of a filter material.30. The catheter of claim 23, wherein said one or more porous windowcomprises a filter.
 31. A catheter for perfusing a branch lumenconnected to an aortic arch lumen in a patient comprising: a cathetershaft having a distal end, a proximal portion and a flow control memberpositioned between said proximal portion and said distal end, said flowcontrol member having a porous portion, at least one occlusive end andhaving an interior chamber in fluid communication with a perfusion lumenextending along the length of said catheter shaft from at least oneperfusion port positioned within said interior of said flow controlmember to an external perfusion pump located outside the patient's aortawherein said at least one perfusion port is sized and configured toexpand said flow control member to a size sufficient to occlude apatient's aorta and to provide adequate flow to the arch vessels throughsaid porous portion to sustain the metabolic demands of the brain; and acorporeal perfusion lumen having a distal end configured to resideinside the internal lumen of the patient's aorta when placed in anoperative position and a proximal portion extending outside the bodylumen of the patient configured for being coupled to said externalperfusion pump and of sufficient size and internal diameter tocommunicate fluid from said external perfusion pump to at least onecorporeal perfusion port to sustain the metabolic demands of thecorporeal body.
 33. The aortic catheter of claim 32, wherein said porousportion comprises one or more porous windows.
 34. The catheter of claim32, wherein said porous portion has a deployed diameter less than thedeployed diameter of said occlusive end.
 35. The catheter of claim 32,wherein a known rate of perfusion can be established by adjusting thepressure within the flow control member.
 36. The catheter of claim 32,further comprising at least one auxiliary flow control member coupled tosaid elongated catheter distal to said flow control member.
 37. Thecatheter of claim 32, further comprising at least one auxiliary flowcontrol member coupled to said elongated catheter proximal to said flowcontrol member.
 38. The catheter of claim 32, wherein said porousportion comprises a filter.
 39. The catheter of claim 32, wherein saidporous portion is comprised of a filter material.
 40. The catheter ofclaim 33, wherein said one or more porous window comprises a filter. 41.A method of perfusing a patient's aorta comprising the steps of: (a)providing a catheter shaft having a flow control member positionedthereon, said occlusion member having a porous portion, at least oneocclusive end and an interior chamber in fluid communication with aperfusion lumen extending at least in part along the length of saidcatheter shaft from an external perfusion pump located outside thepatient's aorta to at least one perfusion port positioned within saidinterior of said flow control member; (b) positioning said flow controlmember in the aorta of the patient such that said porous portion isarranged in a relationship with at least one branch vessel of the aorta;and (c) perfusing the aorta such that at least one branch vesselreceives flow to sustain the metabolic demands of an organ system. 42.The method of claim 41, wherein the organ system is the brain.
 43. Themethod of claim 42, further comprising the step of: perfusing the bodythrough a corporeal perfusion lumen coupled to said external perfusionpump.
 44. The method of claim 42, further comprising the step of:perfusing the body through a corporeal perfusion lumen coupled to saidexternal perfusion pump wherein said corporeal perfusion lumen extendsthrough said catheter shaft.
 45. The method of claim 42, furthercomprising the step of: perfusing the body through a corporeal perfusionlumen coupled to said external perfusion pump wherein said corporealperfusion lumen is a separate catheter.
 46. The method of claim 42,further comprising the step of: perfusing the body through a corporealperfusion lumen coupled to said external perfusion pump wherein saidcorporeal perfusion lumen is a separate catheter inserted into aperipheral artery.
 47. The method of claim 42, further comprising thestep of: perfusing the body through a corporeal perfusion lumen coupledto said external perfusion pump wherein said corporeal perfusion lumenis a separate catheter inserted into a femoral artery.
 48. The method ofclaim 42, further comprising the step of: perfusing the body through acorporeal perfusion lumen coupled to said external perfusion pumpwherein said corporeal perfusion lumen is a separate catheter insertedinto a subclavian artery.
 49. The method of claim 41, further comprisingthe step of: expanding the interior chamber of said flow control membersuch that at least one occlusive end prohibits flow in the ascendingaorta and fluid flows through said porous portion.
 50. The method ofclaim 49, further comprising the step of: arresting the heart.
 51. Themethod of claim 41, wherein: step (a) is carried out with a flow controlmember having one or more porous window.
 52. The method of claim 41,further comprising the step of: deploying said flow control member suchthat the deployed diameter of said porous portion is smaller than thediameter of the lumen of the aortic arch.
 53. The method of claim 41,further comprising the step of: deploying said flow control member suchthat the deployed diameter of said porous portion is at least as largeas the aortic lumen of the aortic arch.